Since September 15, 2023, the Investigational In Vitro Diagnostic Medical Device Dossier (IMDD-IVD) template is available on the CCMO website. The IMDD-IVD can be used for IVD performance studies that fall under Article 58 of IVDR. Until January 1, 2024, the use of the IMDD-IVD is optional for new submissions. After this date, the applicant is strongly recommended to use the IMDD-IVD.
The document can be found via D2. Investigational In Vitro Medical Device Dossier (IMDD-IVD) | Researchers | Central Committee on Human Research (ccmo.nl).
The document can be found via D2. Investigational In Vitro Medical Device Dossier (IMDD-IVD) | Researchers | Central Committee on Human Research (ccmo.nl).